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P/N 53063-50, Manual Revision: B

Appendices

APP-11

A

PPENDIX

D: IEC 60601-1

STANDARD

REQUIREMENTS

Caution:

The Cell Saver device must be operated in an environment compatible

to the requirements of the IEC 60601-1-2 Standard, Electromagnetic
compatibility.

Operation
precautions

To comply with the IEC 60601-1-2 Standard for Medical Electrical Equipment,
general requirements for safety, it is not permitted to power the Cell Saver device
using a power cord not supplied by Haemonetics, a multiple portable socket
outlet or an extension cord.

Mobile RF communication equipment not approved by Haemonetics and
portable communication equipment can affect the system. Any accessories and
cables not approved by Haemonetics used in conjunction with the device may
increase hazards and influence compatibility with EMC requirements. Therefore,
non-approved accessories and cables must not be used.

In addition, the Cell Saver device and accessories must not be placed directly
adjacent to, or top of other equipment, unless specifically approved by
Haemonetics.

Electromagnetic
immunity

The Cell Saver system is intended for use in the electromagnetic environment
specified in the following tables and the operator must ensure that each system
is used in such an environment.

.

IEC 60601-1-2: 2001, Table 201: Guidance and manufacturer’s declaration - electromagnetic emissions

The Cell Saver system is intended for use in the electromagnetic environment specified below. The customer
or the user of the Cell Saver system should assure that it is used in such an environment.

Emissions test

Compliance

Electromagnetic environment guidance

RF emissions
CSIPR 11

Group 1

The Cell Saver system uses RF energy only for its internal
functions. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic equipment.

RF emissions
CSIPR 11

Class A

The Cell Saver system is suitable for use in all establishments other
than domestic and those directly connected to the public low
voltage power supply network that supplies buildings used for
domestic purposes.

Harmonic
emissions
IEC 61000-3-2

Class A

Voltage
fluctuations/
flicker emissions
IEC 61000-3-3

Complies

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Содержание Cell Saver 5+

Страница 1: ...ous Blood Recovery System Operator s Manual Haemonetics Corporation 400 Wood Road Braintree Massachusetts 02184 USA P N 53063 50 Manual revision B 1993 2000 2004 Haemonetics Corporation All rights res...

Страница 2: ...Preface P N 53063 50 Manual Revision B ii...

Страница 3: ...rs of the Haemonetics Cell Saver 5 Autologous Blood Recovery System The contents of this Operator s Manual explain the operation and basic maintenance for the Cell Saver 5 System Diagnostics and subse...

Страница 4: ...and as a supplement to the training supplied by a Haemonetics Clinical Specialist or other qualified personnel Departures or deviations from the procedures contained in this manual should not be made...

Страница 5: ...62 CH 1274 Signy 2 Switzerland Haemonetics Japan Co Ltd Shin Kojimachi Building 1 2F 4 3 3 Kojimachi Chiyoda ku 102 Tokyo Japan In the United States telephone inquiries may be made by using the toll f...

Страница 6: ...86 21 5066 3366 Fax 86 21 6841 3688 Haemonetics CZ spol s r o Pta nsk ho C 8 60200 Brno Czech Republic Tel 42 05 4121 2400 Fax 42 05 4121 2399 Haemonetics France S A R L 46 bis rue Pierre Curie Z I L...

Страница 7: ...ell Saver Systems 1 7 Special features of the CS5 1 8 Automated Operation 1 8 Computer Guided Setup 1 9 Performance Readouts 1 9 Specifications 1 10 Dimensions and Weight 1 10 Maneuverability and Port...

Страница 8: ...Bowls 2 20 Emptying the Bowl 2 20 Chapter 3 Safety and Patient Care Precautions General 3 2 Safety and patient care precautions 3 3 Storage and Handling of Disposables 3 3 Flammable Locations 3 3 Elec...

Страница 9: ...INE RETURN Option 5 13 VOLUME TO RESERVOIR CIRCUIT 5 13 NO WASH Option 5 15 EMERGENCY Option 5 17 EMPTY BLUE LINE Option 5 18 System status 5 19 Wash Volume Monitor 5 20 Volume Accounting Function 5 2...

Страница 10: ...leaning After a Spill 8 4 Cleaning the Air Filter 8 4 Field service 8 6 Technical services 8 7 Installation and Training 8 7 Hotline 8 7 Returned goods authorization RGA system 8 8 RGA Procedure 8 8 C...

Страница 11: ...Systems 1 7 SPECIAL FEATURES OF THE CS5 1 8 Automated Operation 1 8 Computer Guided Setup 1 9 Performance Readouts 1 9 SPECIFICATIONS 1 10 Dimensions and Weight 1 10 Maneuverability and Portability 1...

Страница 12: ...ets activated clotting factors extracellular potassium free hemoglobin anticoagulant and cardioplegia The washed concentrated RBCs may then be returned to the patient Use of the CS5 should be consider...

Страница 13: ...P N 53063 50 Manual Revision B Introduction 1 3 Figure 1 1 The Haemonetics Cell Saver 5 Autologous Blood Recovery System...

Страница 14: ...e Haemonetics Cell Saver 5 System may also be used for preoperative platelet and plasma sequestration Contraindications for Use The risk benefit ratio of blood salvage must be determined on an individ...

Страница 15: ...n are well documented The major advantages are as follows No disease transmission risk Reduced risk of transfusion reactions Minimal compatibility testing Reduced demand on blood bank inventory Cell S...

Страница 16: ...1800 s James Highmore an English surgeon proposed the use of autotransfusion as autologous transfusion is also known and suggested that a patient s shed blood was an overlooked source that could be u...

Страница 17: ...mply anticoagulated filtered and reinfused The Bentley machine was the first attempt to modernize autologous blood recovery in decades HaemoneticsCell Saver Systems Haemonetics Cell Saver Systems are...

Страница 18: ...istently optimal results under most operating conditions Although it is possible to reprogram the parameters changes should be carefully considered The ultrasonic air detector monitors the fluid flow...

Страница 19: ...the instruction and continues from that point Caution The instructions provided by the display panel are not intended to replace formal training by Haemonetics in the operation of the Cell Saver 5 Sy...

Страница 20: ...andle will pivot outward from the left side of the latch Pull on the handle to ensure the lock is completely disengaged To remove the machine from the cart lift the machine Machine Installation There...

Страница 21: ...turn the small handgrip above the reservoir ring counterclockwise raise or lower the pole as needed and turn the handgrip clockwise to tighten Hooks and a waste bag weigher are provided on the front o...

Страница 22: ...500 Wash 300a 400 500 Empty Returnb 400 250 200 400 250 200 500 Concentrate 250 450 350 70 ml bowl Fill 125 125 Wash from FILL 100 100 Wash from CONC 75 75 Empty Return 100 100 Concentrate 75 75 Sequ...

Страница 23: ...d floating applied part providing adequate protection against electrical shock particularly regarding allowable leakage currents and reliability of the protective earth connection Alternating Current...

Страница 24: ...mber Expiration date Lot number Contents sterile by exposure to ethylene oxide Fluid path sterile by exposure to ethylene oxide Do not reuse Caution consult operator manual for instructions Storage co...

Страница 25: ...4 amp surge At 220 Vac 1 3 amp steady state 2 amp surge d Power Cord Detachable 16 foot 4 9m E 183553 C 18 low leakage SJT P 350 HAR VDE tested e The Cell Saver 5 has UL approval f Input Fuse Rating M...

Страница 26: ...use 244 Sequestering Kit Sterile disposable for single patient use 245 High Speed Reinfusion Bag 1 liter capacity Sterile disposable for single patient use 246 High Speed Waste Bag 10 liter capacity S...

Страница 27: ...Pack with Filtered Reservoir Includes LN 261 Basic Cell Saver 5 Bowl Set LN 220 Blood Collection Reservoir LN 208 Basic Aspiration and Anticoagulation Assembly 291A Basic Mini Volume 70 ml Cell Saver...

Страница 28: ...s on the Transfusion of Blood by the Syringe Medico chirurgical Trans 9 56 92 Feb 3 1818 5Highmore William Overlooked Source of Blood Supply for Transfusion in Post Partum Hemorrhage Lancet Jan 17 187...

Страница 29: ...tch and Fusing 2 4 Display Panel 2 4 Control Panel 2 5 MAJOR COMPONENTS 2 9 Hardware 2 9 Disposables 2 13 GENERAL OPERATION 2 18 Blood Collection 2 18 Filling the Centrifuge Bowl 2 19 Cell Separation...

Страница 30: ...Description P N 53063 50 Manual Revision B 2 2 Figure 2 1 Cell Saver 5 components Pigtails for Saline Anticoagulant and Reinfusion Bags Reservoir Pump Centrifuge Waste Tubing Manifold Control Display...

Страница 31: ...s A general description of the operation of the system is also provided For detailed setup and operating instructions for the various protocols performed by the CS5 please refer to Chapters 3 through...

Страница 32: ...ne The secondary fuse is internal on the power supply and should only be replaced by trained service personnel Display Panel The display panel of the CS5 provides important information regarding the f...

Страница 33: ...ol Panel Only Start Stop Mode and Help are permanently visible as shown in Figure 2 4 Figure 2 4 Control panel automatic WASH CELLS Processed Vol Wash Vol Reinfusion Vol Bowls Processed Pump Rate Wash...

Страница 34: ...be used in either Manual or Auto modes of operation START Initiates or resumes processing after the process is stopped or paused Can be used in either Auto or Manual mode of operation STOP Stops the...

Страница 35: ...ml min in Automatic Sequester Raises the pump speed in increments of 10 ml min to a maximum of 250 ml min in FILL and CONC and in increments of 25 ml min to a maximum of 1000 ml min for EMPTY Cell Sa...

Страница 36: ...or the operator to press The operator can easily revert to Automatic control by pressing the MODE key to switch back to AUTO processing Pressing this key twice within two seconds while in Automatic op...

Страница 37: ...reinfusion bag Pump Fluids are moved in and out of the centrifuge bowl by a 3 roller occlusive pump At its maximum speed it is capable of a flow of 1000 ml min Air Detector This device ultrasonically...

Страница 38: ...nly seated in the centrifuge chuck If the centrifuge chuck spins with the bowl base or adapter not evenly seated as indicated by bowl wobbling or noise bowl damage will occur and the procedure must be...

Страница 39: ...r checks the weight of the fluid in the waste bag alerting the operator when it is almost full and also when it is full In the Automatic mode the message EMPTY WASTE BAG is displayed when approximatel...

Страница 40: ...p Regulation OFF mode is selected the effluent line sensor will still monitor effluent line quality in WASH mode and extend washes appropriately as described above This option is available on a per pr...

Страница 41: ...The three lines are joined at a tubing manifold see Figure 2 8 A clamped line sensor is located under the blue line to warn of occluded lines during EMPTY and RETURN After the junction the single lin...

Страница 42: ...t may be used with the Cell Saver 5 System Centrifuge Bowl The central part of the disposable is the centrifuge bowl It is in this bowl that the RBCs are separated concentrated and washed As indicated...

Страница 43: ...outlet port is inadvertently closed the blood being processed may be compromised by friction or heat rendering it inappropriate for reinfusion See Chapter 3 for more information Figure 2 10 The centr...

Страница 44: ...creases to approximately 50 4 In WASH saline circulates through the RBC layer and displaces the waste 5 The overflow runs clear Free hemoglobin and anticoagulant are in the waste bag 6 In EMPTY the bo...

Страница 45: ...ill give an hematocrit of approximately 50 for the washed cells Figure 2 12 Red cell interface The hematocrit may be increased by filling the bowl until the red cell interface is closer to the center...

Страница 46: ...er the loading sequence or the first FILL mode Blood Collection The collection of blood is the simplest of the Cell Saver System s tasks The blood is collected into a collection reservoir such as the...

Страница 47: ...optical RBC sensor located in the centrifuge well will detect that the RBC content of the bowl is sufficient approximately 50 hematocrit to warrant washing When utilizing the 70 ml bowl the effluent...

Страница 48: ...ontents is lower there is more supernatant in the bowl In order to dilute the larger volume of supernatant two times the normal wash solution usually 2 x 1000 ml is needed Emptying the Bowl After the...

Страница 49: ...ing Machinery 3 4 Communicable Disease 3 4 Restrictions to Flow 3 4 Twists and Kinks in Tubing 3 5 Plasma Hemoglobin 3 5 Continuous Aspiration 3 5 Overheating 3 5 Red Cell Spillage 3 6 Managing the In...

Страница 50: ...re Precautions P N 53063 50 Manual Revision B 3 2 GENERAL Chapter 3 provides general information on Safety and Patient Care Precautions for the Cell Saver 5 System CS5 and discusses parameters that af...

Страница 51: ...sure to chemical vapors Avoid contaminating the surface of disposable plastic components with chemicals by making sure that hands or gloves contacting the plastic surface are clean and dry Flammable L...

Страница 52: ...ctated by the medical facility s Infection Control Plan as legally required by the OSHA Blood Borne Pathogen Standard When any Haemonetics product equipment or disposables which has been used during a...

Страница 53: ...ee See Appendix C Machine messages troubleshooting on page APP 8 Continuous Aspiration Continuous aspiration of profuse bleeding without breaks in suction can cause electrical interference If the Cell...

Страница 54: ...essure Reinfusion Warning Do not use a pressure cuff or any other mechanical device with the Cell Saver 5 System Pressure reinfusion can result in the fatal infusion of air into the patient The user w...

Страница 55: ...may be contraindicated for example in the case of sepsis or malignancy The responsibility for the use of this device belongs solely to the physician in charge Anticoagulant Use Anticoagulant solutions...

Страница 56: ...ssing time for any cell salvage system The CS5 has been programmed to optimize this time during each procedure without compromising the final product Any changes made to the preset processing paramete...

Страница 57: ...4 1 Chapter 4 Setup Procedures for Cell Salvage GENERAL OPERATION 4 2 SETUP 4 3 Power On Procedure 4 3 Installing the Cell Saver Disposables 4 5...

Страница 58: ...5 System CS5 and required disposable components The following sections describe the basic setup regardless of how the system will be operated for a Cell Saver procedure Note Machine should be powered...

Страница 59: ...d like to retain the data from before the unit was turned off Press NO to start a new procedure The unit then goes into self test to insure that all the functions are operating before the unit is allo...

Страница 60: ...n Note Do not load disposables until the self test is complete After the system self test the display will change to the following message Figure 4 4 Installing the Cell Saver Disposables SELF TEST UN...

Страница 61: ...a substitute for formal Haemonetics training on the use of the CS5 1 Prepare the Collection Standby Install a collection reservoir and close the reservoir drain clamp Open the Aspiration and Anticoagu...

Страница 62: ...should be delivered at a 1 7 ratio for anticoagulant to blood entering the reservoir by adjusting the roller clamp on the anticoagulant line to approximately 1 drop per second Note Citrate solution c...

Страница 63: ...Lift the bowl out of the tub center and place it firmly into the centrifuge well or into the white centrifuge adapter ensuring the red indicator lines are visible 70m ml bowl Push the bowl or adapter...

Страница 64: ...deep into the effluent line sensor notch Figure 4 10 Thread Tubing through Line Sensor 4 Hang the Bags Hang the reinfusion bag on the IV pole Close the two small clamps on the bag Ensure that the lar...

Страница 65: ...l the tubing harness Floss the tubing through the air detector Thread the pump tubing around the pump Place the tubing manifold in the slots Figure 4 13 Install Tubing Manifold Engage the manifold doo...

Страница 66: ...the saline bags Spike the containers of normal saline and open the clamps on the lines Figure 4 14 Hang the saline wash containers on the IV pole Figure 4 15 Close the ratchet clamps on both spikes b...

Страница 67: ...iable parameters These parameters may be changed by pressing the MODIFY key Similar screens appear when using the 70 ml bowl CURRENT SETTINGS Press START to begin procedure Press MODIFY to change sett...

Страница 68: ...to Chapter 7 If the Cell Saver protocol is chosen after all modifications have been completed press the MODIFY key to return to the current settings screen Then press START to proceed to STANDBY The...

Страница 69: ...IONAL FUNCTIONS IN AUTOMATIC 5 11 CONC Concentrate Option 5 11 PUMP REGULATION Option 5 12 EMPTY RBCs TO BLUE RED LINE RETURN Option 5 13 VOLUME TO RESERVOIR CIRCUIT 5 13 NO WASH Option 5 15 EMERGENCY...

Страница 70: ...Automatic Operation Cell Salvage P N 53063 50 Manual Revision B 5 2 GENERAL This section explains how to operate the Cell Saver 5 CS5 Autologous Blood Recovery System in the AUTOMATIC mode...

Страница 71: ...BY the operator can initiate a FILL MODE by pressing start or the backlit fill key when it is illuminated Note The preset parameters can also be modified at this time including adjusting the preset le...

Страница 72: ...vary as the bowl is being filled The CS5 will operate at default settings when using the 70 ml bowl Pump speeds will not vary with the 70 ml bowl 4 If the reservoir empties before the bowl is full th...

Страница 73: ...bris free HgB heparin or other anticoagulant activated clotting factors etc into the waste bag The following display will be shown while the system is in the WASH mode Pressing YES will double the pro...

Страница 74: ...ts for the 70 ml bowl until the effluent line is clear Pump speed may be adjusted in AUTOMATIC by utilizing the UP and DOWN arrow keys If the pump speed is increased and an RBC spill occurs reengage t...

Страница 75: ...of the waste bag The system will sound an audible signal and the system will move into a PAUSE state and indicate the waste bag is full Once corrective action is taken press START to resume processin...

Страница 76: ...l and detach the bag These red blood cells are now ready for transfusion following standard transfusion protocols Warning In accordance with FDA guidelines and AABB standards a transfusion filter capa...

Страница 77: ...START to resume processing If 90 or more of the wash volume has been pumped then the system advances to EMPTY Warning At anytime during the Automatic operation the operator can advance the system to M...

Страница 78: ...ANDBY Note All modifications to the preset parameters will be retained from procedure to procedure until reprogrammed by the operator with the following exceptions 1 A minimum wash volume below 1000 m...

Страница 79: ...produce a low hematocrit end product The operator can access the CONC option in AUTO mode when during a FILL mode the system senses an empty reservoir and the system goes into STANDBY At this point t...

Страница 80: ...any time during operation Once the MODIFY key is pressed a screen similar to the following is displayed 1 To turn off the Pump Regulation option use the SELECT key to highlight the Pump Regulation opt...

Страница 81: ...he blood is returned to the reservoir for reprocessing If Volume to Circuit is chosen the Processed Volume and Reinfusion Volume will increase as the blood is returned directly to the patient via the...

Страница 82: ...the CS5 to accurately account for the volume processed and reinfused to the patient 3 Press MODIFY to return to the STANDBY screen CELL SAVER SETUP Press ARROW keys to change values Press SELECT to ad...

Страница 83: ...ASH mode thus reducing the processing time to the length of the FILL EMPTY modes Warning The no wash option should only be selected after the physician has performed a careful assessment of the risk b...

Страница 84: ...e processed blood will still contain anticoagulant increased free hemoglobin and other cellular debris normally removed by the washing process The surgeon anesthesiologist should be advised of this de...

Страница 85: ...trate or RETURN cells to the reservoir while in the emergency option Parameters in EMERGENCY Option The preset parameters in the EMERGENCY mode are If the air plasma interface has not yet been detecte...

Страница 86: ...Blue Line Y N If the YES key is pressed the machine will empty the line at 100 mL min and then enter STANDBY If the NO key is pressed the machine will enter STANDBY without emptying the line Warning...

Страница 87: ...ne solution have been used a total of 2525 ml of volume has been processed from the reservoir and 450 ml of concentrated RBCs have been sent to the reinfusion bag To increase the pump speed temporaril...

Страница 88: ...nel displays a running cumulative total of wash solution used on the current WASH mode on the left hand side of the display as shown in the following figure This counting function returns to zero each...

Страница 89: ...ay cause the Volume Accounting Function to overestimate the PROCESSED VOLUME Because the red reservoir line contains no fluid whenever the reservoir is drained the air in the length of tubing from the...

Страница 90: ...r can manage a large portion of these problems by pressing HELP on the Cell Saver 5 for troubleshooting assistance The Machine Messages chart in Appendix C describes some situations that may happen an...

Страница 91: ...6 1 Chapter 6 Manual Operation GENERAL 6 2 CONTROLS AND INDICATORS 6 3 MANUAL OPERATION 6 4 EMERGENCY Option 6 8...

Страница 92: ...go directly from FILL to EMPTY After the centrifuge bowl has been stopped the red cell separation is lost This settling of cells could lead to a red cell spillage if when restarting fluid is pumped i...

Страница 93: ...Figure 6 1 Control panel MANUAL STANDBY The display panel will also give you indication of which mode you are in as shown in the following figure The operator can easily move back to AUTO operation b...

Страница 94: ...rameters are still in effect in the manual mode It is possible to reprogram parameters such as pump speed for the manual mode the reprogramming process is the same for both automatic and manual modes...

Страница 95: ...bowl filling press the CONC key This will cause the blue valve to open bringing blood down from the reinfusion bag into the bowl These red cells will displace the supernatant forcing the supernatant...

Страница 96: ...e 70ml bowl During EMPTY the display will read A Centrifuge Stopping message will blink on the screen until the centrifuge comes to a complete stop The concentrated red cells are pumped from the bowl...

Страница 97: ...rom the reinfusion bag see the section Pressure Reinfusion in Chapter 3 Warning Washed concentrated cells are depleted of clotting factors The physician must monitor the quantity of washed cells retur...

Страница 98: ...arameters can all be modified from the STANDBY state or some parameters can be changed at various points in the processing cycle To modify the preset parameters the operator should 1 Press the MODIFY...

Страница 99: ...ERAL 7 2 OVERVIEW OF THE SEQUESTERING PROTOCOL 7 3 Loading the Disposable Set 7 3 Setting the Parameters 7 4 METHOD 1 MANUAL SEQUESTRATION 7 7 System Breakdown 7 11 METHOD 2 ASSISTED SEQUESTER MODE 7...

Страница 100: ...3 50 Manual Revision B 7 2 GENERAL This section explains how to perform sequestering on the Cell Saver 5 CS5 Autologous Blood Recovery System This protocol allows for the separation of platelet rich p...

Страница 101: ...or optimal performance along with prompts to assist the operator with steps of the process The Manual Sequester Mode allows the operator to select desired processing parameters and provides no operato...

Страница 102: ...ep 10 Close the red clamps on the product bags and ensure that the tub ing and cap connections to the product bags are secure Step 11 Ensure that the white product bag clamps are open Setting the Para...

Страница 103: ...F Fill Bowl DRAW Rate 60 ml min Fill Bowl Centrifuge Speed 4750 rpm Return Plasma NO Press ARROW keys to change values Press SELECT to advance highlight Min Wash Vol 225 125 Reservoir Level Resume at...

Страница 104: ...the collection bag clamps are closed unless using the PPP bag for air management Ensure that while the bowl is filling the air in the disposable system is entering the AIR bag The air will be emptied...

Страница 105: ...YELLOW PPP bag clamp are closed Open the air bag clamp Note If the PPP collection bag will be used for system air management ensure that the yellow bag clamp is open and the sir bag clamp is closed b...

Страница 106: ...r the PRP bag When the effluent line from the bowl turns medium red indicating the presence of red cells allow the machine to continue processing for approximately 30 ml and then press the EMPTY key t...

Страница 107: ...ntrifuge will briefly rotate in both directions to expedite the removal of the red cells from the bowl The following display will be shown 125 ML EMPTY BOWL Processed Vol Reinfusion Vol Bowls Processe...

Страница 108: ...hen returning processed concentrated red cells 10 If another pass is desired the entire procedure may be repeated using Steps 1 through 7 until the desired volume of PPP PRP has been collected Note Th...

Страница 109: ...epted for blood donation Therefore unless the blood passes AABB or hospital donation standards the products obtained in autotransfusion or plasma sequestration procedures must be labeled for autologou...

Страница 110: ...ess START 9 The CS5 is now set up for normal Cell Saver procedure Ensure that the reservoir is properly set up with its clamp open and press START to begin the cell salvage procedure in Automatic or p...

Страница 111: ...TER SETUP screen is displayed The following table indicates the modifiable parameters in the Sequester mode of those machines equipped with Assisted Sequester The table indicates the default setting o...

Страница 112: ...the PRP collection is considered complete Return Plasma This question is asked to determine which clamps to prompt the operator to open and close at the beginning of the EMPTY phase and to account for...

Страница 113: ...ssing the NO key selects the air bag 3 Once a selection is made for system air management the display changes to the following to assist the operator in final setup confirmation of the disposable set...

Страница 114: ...and platelets and then red cells The following screen will be shown STANDBY Processed Vol Reinfusion Vol Bowls Processed Press START to fill bowl or CONC to concentrate SEQUESTER Press MODIFY to chang...

Страница 115: ...the operator to open the YELLOW PPP bag clamp and close the air bag clamp Once this is completed the machine waits for the START key to be pressed to continue processing as shown in the following scr...

Страница 116: ...sing the NO key If a high volume bowl is being used the operator can press the YES key or nothing Once a key is pressed or 15 seconds has elapsed the pump restarts and the machine continues processing...

Страница 117: ...tor is prompted to open the BLUE PRP bag clamp and close the YELLOW PPP bag clamp Once this is completed the machine waits for the START key to be pressed to continue processing as shown in the follow...

Страница 118: ...es PRP is being collected into the PRP collection bag and the PRP Volume on the display is incrementing along with the Processed Volume If the Milk PRP Collection Layer parameter in the Sequester Setu...

Страница 119: ...the operator in the Sequester Setup Note If the sensor tubing is not properly installed in the line sensor the CS5 will not detect the red blood cells spilling into the PRP collection bag and the CS5...

Страница 120: ...TART key must be pressed to empty the contents of the bowl If the Return Plasma parameter in the Sequester Setup is set to NO the following screen is displayed 125 ML PRP Processed Vol Reinfusion Vol...

Страница 121: ...both directions to expedite the removal of the red cells from the bowl The following display will be shown 125 ML EMPTY BOWL Processed Vol Reinfusion Vol Bowls Processed Press START to empty bowl SEQ...

Страница 122: ...urning processed concentrated red cells 17 If another pass is desired the entire procedure may be repeated using Steps 5 through 14 until the desired volume of PPP PRP has been collected Note The conc...

Страница 123: ...been accepted for blood donation Therefore unless the blood passes AABB or hospital donation standards the products obtained in autotransfusion or plasma sequestration procedures must be labeled for...

Страница 124: ...normal Cell Saver procedure Ensure that the reservoir is properly set up with its clamp open and press START to begin the cell salvage procedure in Automatic or press the MODE key to proceed with Manu...

Страница 125: ...3 Cleaning the Effluent Line Sensor 8 4 Air Detector Cleaning 8 4 Cleaning the Tubing Valves 8 4 Blood Pump Cleaning 8 4 Cleaning After a Spill 8 4 Cleaning the Air Filter 8 4 FIELD SERVICE 8 6 TECHN...

Страница 126: ...t maintenance will consist of cleaning the system and assuring that the pump rollers are clean and free rolling The date and type of maintenance performed should be recorded regularly Warning Do not g...

Страница 127: ...can be dampened with a mild detergent spray to improve cleaning Do not use 100 bleach directly on the machine a bleach water solution or some other disinfectant may be indicated Follow by drying with...

Страница 128: ...p under the faucet with warm water If required pump rotor can be cleaned in an ultrasonic cleaner Dry thoroughly Cleaning After a Spill The exterior of the CS5 including the control panel should be cl...

Страница 129: ...rasp the filter and pull it out 4 Rinse the filter under warm running water until it is clean Do not use soap or any cleaning solution 5 Squeeze out excess water place on a clean cloth and allow to dr...

Страница 130: ...ervice engineers If a problem should arise one of these equipment specialists can usually be on site within twenty four hours to diagnose and correct any malfunction Your field service engineer also c...

Страница 131: ...concerns Upon delivery of your Haemonetics instrument thorough on site training of personnel will be arranged at your convenience Should the application or staff change as the program grows additiona...

Страница 132: ...0 225 5297 1 Call the Product Complaint Coordinator at 800 433 3431 for return of any product felt to be unacceptable for patient use damaged packaging broken component etc 2 The Product Complaint Coo...

Страница 133: ...by the medical facility s Infection Control Plan as required by OSHA Blood Borne Pathogen Standard Repackaging of equipment or disposables for return to Haemonetics must comply with U S Department of...

Страница 134: ......

Страница 135: ...ND CONTRAINDICATIONS APP 2 References APP 6 APPENDIX B CLEANING PROCEDURES APP 7 APPENDIX C MACHINE MESSAGES TROUBLESHOOTING APP 8 APPENDIX D IEC 60601 1 STANDARD REQUIREMENTS APP 11 Operation precaut...

Страница 136: ...tact agent May clot off system Avoid aspiration in area where product is being used Resumption is an option after copious irrigation with 0 9 sodium chloride solution to an alternate suction source 3...

Страница 137: ...eing used Resumption is an option after copious irrigation with 0 9 sodium chloride solution to an alternate suction source 8 Lactated Ringers in presence of citrate anticoagulant Calcium present may...

Страница 138: ...bag and transfer pack or infusion set E Gastric and Pancreatic Fluid Proteolytic enzyme may cause red cell lysis Do not aspirate into system Resumption is an option after copious irrigation with 0 9 s...

Страница 139: ...dy systemic Use at discretion of surgeon C Pheochromocytoma Potential for marked hypertension due to high concentrations of catecholamines Avoid aspirating at the tumor site Resumption is an option af...

Страница 140: ...laneous A Titanium Alloy Prosthesis Effect of darkened tissue or clots blue green black surrounding prosthesis unknown to systemic circulation Discontinue cell salvage until the prosthesis and all dar...

Страница 141: ...if necessary Control Panel 1 Wipe the control panel with a mild detergent dampened cloth 2 Wipe with a lint free cloth dampened with clear water 3 Dry with a lint free cloth Effluent Line Sensor 1 Fl...

Страница 142: ...been detected in the centrifuge well FILL LOAD DISPOSABLE 1 Press YES if using the white bowl adapter 2 Press NO if NOT using the bowl adapter CENTRIFUGE COVER NOT CLOSED Centrifuge does not operate...

Страница 143: ...f bag is empty press STOP to wait for more salvaged blood or press WASH to complete cycle 2 If bag is not empty Check tubing in air detector Check tubing in valves for correct placement PUMP ERROR Pum...

Страница 144: ...eck waste bag and weigher 3 Check reservoir placement and reservoir tubings placement 4 Ensure red and blue line clamps are open and no kinks or occlusions are in tubing 5 Clean sensor and tubing 6 Cl...

Страница 145: ...r equipment unless specifically approved by Haemonetics Electromagnetic immunity The Cell Saver system is intended for use in the electromagnetic environment specified in the following tables and the...

Страница 146: ...4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions...

Страница 147: ...termined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with the following symbol NOTE...

Страница 148: ...d maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5GHz 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17...

Страница 149: ...2 5 1 6 2 6 8 7 12 7 26 Automatic Controls 2 5 2 8 2 17 Avitene APP 2 B Betadine APP 2 Blood Spill 8 3 APP 7 Blue Line 2 9 2 13 5 8 5 13 C Caution iii Citrate Solution 3 7 4 6 Clamped Line Sensor 2 11...

Страница 150: ...3 3 EMERGENCY Option 2 6 2 12 5 17 6 8 Emergency Option 2 8 EMPTY 2 7 2 20 3 5 5 8 5 13 5 18 6 2 6 6 7 6 7 8 Empty 1 12 Empty Rate 1 12 5 17 6 8 Environmental Conditions 1 15 F Factors affecting proc...

Страница 151: ...ensor 8 4 M Machine Symbol Chart 1 13 Maintenance 8 3 Malignancy 1 4 APP 5 Managing the Inventory of Air 3 6 Manifold 4 7 4 9 Manual 2 5 2 6 2 8 6 1 Manual Controls 2 8 Minimum Wash Volume 2 20 5 5 5...

Страница 152: ...Plasma PRP 7 2 7 3 7 8 7 14 7 15 Power Cord 1 15 Power Switch 2 4 Preset Parameters 5 3 5 10 5 17 6 4 6 5 6 8 7 5 Pressure Cuff 3 6 5 8 Pressure Reinfusion 3 6 5 8 6 7 S Setup 1 9 T Technical Hotline...

Страница 153: ...al Revision B Index IX 5 W Warning iii Warranty iv Wash Rate 1 12 5 5 5 17 6 5 Wash Solution 2 19 2 20 Washing Partial Bowls 2 20 Waste Bag 1 16 2 11 2 12 2 13 4 9 5 5 Waste Bag Weigher 2 11 6 2 Y Yel...

Страница 154: ......

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